If the issuance of the “Opinions on Reforming the Review and Approval System for Drugs and Medical Devices” marked the beginning of reforms in this area, then the recently released “Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Drugs and Medical Devices,” issued by the two offices, will further advance structural adjustments and technological innovation within the pharmaceutical and medical device industries.

　　Over the past two years, with the successive introduction of a series of reform policies, review and approval standards and transparency have steadily improved, effectively cleansing the R&D and registration ecosystem. A number of innovative drugs and medical devices have been granted priority market access, the backlog in drug reviews has been largely resolved, work on evaluating the quality and therapeutic equivalence of generic drugs has continued to advance, foundational efforts to classify medical devices have been strengthened, and pilot programs for the marketing authorization holder system have progressed smoothly. However, as reforms deepen, they increasingly encounter complex, underlying challenges. Looking back at the past and forward to the future, how will the reform of the medical device review and approval system move ahead? And how should enterprises seize the opportunities for development? On November 8, during the 29th National Pharmaceutical Economic Information Conference, experts engaged in an open and candid discussion at a high‑level symposium on medical devices.

　 　Six Key Priorities of Post-Market Regulatory Reform for Medical Devices

　　Kong Fanpu, Director-General of the Medical Device Supervision Department of the State Food and Drug Administration

　　At the conference, Kong Fanpu, Director-General of the Medical Device Supervision Department of the State Administration for Market Regulation, stated that, in line with the “Opinions on Deepening the Reform of the Review and Approval System and Encouraging Innovation in Pharmaceuticals and Medical Devices” issued by the General Office of the CPC Central Committee and the General Office of the State Council in early October (hereinafter referred to as the “Opinions”), the Administration will undertake reforms to strengthen post‑market supervision of medical devices. These measures include establishing a direct reporting system for adverse events by marketing authorization holders, improving the medical device re‑evaluation mechanism, ensuring accountability throughout the entire inspection process, and building a professional inspector corps. The reforms will be advanced across six key areas: refining post‑market regulatory frameworks, enhancing the adverse event reporting system, strengthening re‑evaluation procedures, enforcing full‑process inspection responsibilities, developing a professional inspector workforce, and reinforcing oversight of import agents.

　 　Elevate medical device regulation to the legal level.

　　Kong Fanpu pointed out that, in terms of improving post‑market regulatory frameworks and systems, the long-term goal is to draw on accumulated experience, incorporate core provisions into the revision of the Drug Administration Law, and add a dedicated chapter on “Special Provisions for Medical Devices,” with the aim of elevating medical device regulation to the level of law, thereby strengthening regulatory authority and intensifying efforts to crack down on illegal and non‑compliant activities. The immediate tasks include implementing the “Opinions,” amending the Regulations on the Supervision and Administration of Medical Devices, and revising and refining the associated rules and normative documents. This encompasses revising the Regulations on the Supervision and Administration of Medical Devices, as well as formulating or revising regulations such as the Measures for the Supervision and Administration of Online Sales of Medical Devices, the Measures for the Monitoring and Re‑evaluation of Adverse Events Associated with Medical Devices, and the Measures for the Supervision and Administration of Medical Device Production.

　 　Implement the principal responsibility of the registrant or filer.

　　Regarding the improvement of the system for direct reporting of adverse events by registrants or filers, Kong Fanpu stated that the draft Revision to the Measures for the Monitoring and Re‑evaluation of Adverse Events of Medical Devices is being formulated with a focus on reinforcing the principal responsibility of registrants and filers. The revisions specifically address issues such as the nature of the responsibilities they are required to fulfill, the mechanisms for ensuring those responsibilities are met, and the penalties for non‑compliance.

　　This includes: the entity responsible for controlling product risks shall proactively conduct medical device adverse event monitoring. It shall establish monitoring institutions and assign personnel commensurate with its products and scale, and carry out proactive adverse event monitoring for its products. Upon receipt of an adverse event report, it shall conduct investigations, analyses, and evaluations, promptly report the evaluation results, and take proactive measures to control product risks. Failure to conduct adverse event monitoring or report adverse events as required, or failure to cooperate with such efforts, may result in penalties including warnings, fines, orders to suspend production or business operations, and, in severe cases, revocation of the medical device manufacturing license or medical device distribution license by the original issuing authority.

　　 Improve and revise the medical device reevaluation system.

　　Regarding the improvement of the medical device reevaluation system, Kong Fanpu disclosed that the draft revision of the “Administrative Measures for the Monitoring and Reevaluation of Adverse Events of Medical Devices” will stipulate that reevaluations may be initiated either proactively by the registrant or filer, or mandated by the food and drug regulatory authorities, or conducted directly by those authorities. Priority will be given to proactive initiatives by registrants or filers, thereby reinforcing the principal responsibility of enterprises. If the results of a reevaluation indicate that defects posing a risk to human safety cannot be eliminated or controlled, or that the risk–benefit ratio is unacceptable, the registrant or filer shall proactively apply for withdrawal of the marketing authorization and promptly make such information public. Should a registrant or filer fail to submit a withdrawal application when required, the original registration or filing authority shall issue a decision to revoke the registration certificate or cancel the filing.

　 　Implement inspection responsibilities according to the division of administrative powers.

　　Regarding the implementation of full‑process inspection responsibilities, Kong Fanpu explained that, in terms of the division of inspection authorities, the State Administration will strengthen on-site inspections of overseas enterprises and conduct unannounced inspections of domestic manufacturing enterprises. Provincial bureaus will intensify oversight of manufacturing enterprises, carry out targeted and unannounced inspections of distribution and use entities, and regulate third‑party online platforms. Municipal bureaus will reinforce supervision of distribution enterprises and user units, with a particular focus on Class III distributors and medical institutions at Level II and above (inclusive), conducting both targeted and unannounced inspections of these entities. County bureaus will leverage the capabilities of grassroots regulatory stations to strengthen oversight of Class I and Class II distributors and medical institutions below Level II.

　　Kong Fanpu emphasized that any violations discovered during inspections will result in penalties imposed on the individuals responsible. For registrants, filers, manufacturers and operators, and users who contravene the provisions of the Regulations and fall under any of the following circumstances—intentional commission of unlawful acts or gross negligence; serious or egregious violations; violations that have caused severe consequences; or other grave adverse social impacts—in addition to imposing administrative penalties on the entities concerned, the legal representative, principal person in charge, directly responsible supervisors, and other persons bearing direct responsibility may also be subject to fines ranging from 30% to 100% of their income in the preceding year.

　 　Accelerate the development of a dedicated team of inspectors.

　　With regard to building a professional inspector corps, Kong Fanpu stated that efforts will be accelerated to establish dedicated inspector teams at both the national and provincial levels. Inspector staffing ratios, qualifications, and eligibility criteria will be determined based on the workload at each level, and inspectors will be managed through tiered, category‑specific systems. Incentive and disciplinary mechanisms—covering performance evaluation, remuneration, and promotion—will be put in place to attract and retain top talent. At the General Administration level, the priority is to develop a high‑caliber, full‑time inspector workforce with international inspection capabilities, bolstering inspection personnel, securing adequate funding, and intensifying inspection activities, with the goal of achieving full coverage of inspections for high‑risk imported products. At the provincial level, it is also necessary to estimate inspection workloads and, based on the number of Class I, II, and III production enterprises and the annual inspection frequency for each category, scientifically calculate and set appropriate inspector staffing ratios. Localities may conduct their own projections by taking into account the characteristics of production enterprises within their jurisdictions and referencing the General Administration’s calculation methodology.

　　Formulate detailed regulations for the supervision of import medical device agents.

　　Regarding the supervision and administration of import agents, Kong Fanpu stated that the “Measures for the Supervision and Administration of Import Medical Device Agents” are currently being drafted.

　　The key proposals are as follows: First, clarify the quality‑related responsibilities of import agents; fully articulate and enforce specific provisions on agents’ liability for the quality of imported medical devices, stipulating that agents are accountable for the authenticity and legality of all activities related to the products they represent and bear corresponding legal responsibility for the safety and quality of those products. Second, define the legal relationships involved. Authorization letters issued by overseas registrants or filers must be notarized by a competent authority in the country of origin and authenticated by the Chinese embassy or consulate in that country, or otherwise comply with the certification procedures set forth in treaties between China and the country where the evidence is located, thereby ensuring the legal validity of such authorizations. Third, establish comprehensive lifecycle oversight of imported medical devices. Regulatory requirements should be imposed across pre‑market registration and post‑market stages, including product traceability, adverse event monitoring, reevaluation, and recalls, with particular emphasis on establishing robust quality management systems. Agents are required to maintain accurate records of the sales of the imported products they represent within China, ensuring full traceability of product distribution. Fourth, impose entry‑qualification criteria for agents. By setting limits on capabilities, staffing, and scale, these measures will clearly delineate agents’ responsibilities and obligations, thereby enhancing their capacity to fulfill legal duties. Finally, specify the operational requirements for regulatory authorities. The duties and powers of food and drug regulatory agencies at all levels should be clearly defined, granting inspectors the authority to conduct inspections and oversight, and setting forth concrete standards for the implementation of regulatory activities.

　　Accelerating the Review and Approval of Medical Devices

　　Xu Wei, Deputy Director of the Medical Device Technical Review Center of the National Medical Products Administration.

　　At the Medical Device Summit, Xu Wei, Deputy Director of the Medical Device Technical Review Center of the National Medical Products Administration, summarized the recent progress in the review and approval of medical device applications and outlined the center’s key priorities for the next phase.

　　Medical device review completed efficiently.

　　Xu Wei pointed out that, in recent years, despite an increasing workload and staffing shortages, the Medical Device Review Center has overcome challenges and successfully completed its medical device review tasks. Over the past three years, the Medical Device Technical Review Center of the National Medical Products Administration received 11,129 review applications in 2015, 10,815 in 2016, and 6,848 in the first nine months of 2017. Through the Center’s dedicated efforts, it reviewed and approved 10,629, 10,917, and 8,153 applications, respectively, thereby largely ensuring a balanced throughput of product review projects. In July this year, the Center smoothly assumed responsibility for the administrative approval of changes to and renewals of licenses for Class III domestic medical devices and imported medical devices. As of the end of September 2017, it had granted administrative approvals for a total of 1,893 products.

　　Regarding the encouragement of medical device innovation, Xu Wei stated that since the launch of the priority review procedure in January 2017, as of the end of September, the Medical Device Review Center had received a total of 33 applications for priority review and 687 applications for special approval of innovative products, with 143 administrative approvals granted.

　　Xu Wei stated that the Medical Device Review Center has vigorously advanced reforms to its review and approval mechanisms, optimizing review processes and procedures while comprehensively mapping out its existing workflows. The Center has steadily carried out innovative and priority reviews, and actively promoted the development of a quality‑assurance system for review and approval, formulating and issuing the “Provisional Regulations on Quality Management for Medical Device Technical Review” to continuously refine its review management framework. It has also standardized the administration of the Expert Advisory Committee by enacting the “Administrative Measures for the Medical Device Technical Review Expert Advisory Committee” and revising the “Operational Guidelines for Expert Advisory Meetings.” Furthermore, the Center has proactively engaged in external communication and collaboration, issuing the “Regulations on Consultation Management for Medical Device Technical Review” and promulgating the “Administrative Measures for Communication and Exchange in Medical Device Review.” In parallel, it has comprehensively advanced personnel‑system reform, strengthened IT‑based support, and further expanded the scope of information disclosed regarding medical device reviews.

　 　Deepen the reform of the review and approval mechanism.

　　Regarding the next priorities of the Medical Device Review Center, Xu Wei stated that, following the issuance of the “Two Offices” Opinions, the Center will further deepen reforms to its review and approval mechanisms. These efforts will include establishing a project manager system, continuing to refine the project‑team review process, enhancing review requirements related to clinical evaluation, actively advancing the development of a quality‑management system for reviews, and implementing an expert advisory committee system.

　　Meanwhile, the Center will vigorously encourage the research and development of innovative medical devices, continue to ensure high-quality review and approval of such products, and further revise and refine the “Operational Guidelines for the Review of Special Approval Applications for Innovative Medical Devices” and the “Trial Operational Guidelines for the Review of Priority Review Applications for Medical Devices.” It will also strengthen the review of specialized medical devices required for clinical treatment, with particular emphasis on bolstering the technical support underlying the review process, intensifying the formulation and revision of guiding principles, and organizing the completion of the development and revision of 200 technical review guidance documents for medical devices as mandated by the 13th Five-Year Plan, as well as the preparation of 52 guidance documents in 2017. In addition, the Center will coordinate with the Administration to revise relevant laws and regulations and actively participate in international regulatory exchanges. It will advance personnel system reform, conduct research on the establishment of a new review and approval framework, continue to promote talent selection and recruitment, and implement position-based employment management for all staff. Furthermore, the Center will continue to enhance the future‑oriented informatization of medical device review, optimize and reengineer the review system, explore online submission and review processes, establish comprehensive data archives for medical devices, and proactively advance public‑facing information services related to medical device review.

　 　The medical device market’s “golden decade” holds considerable potential.

　　Tao Jianhong, Deputy Director of the Southern Institute of Pharmaceutical Economics under the CFDA and Editor-in-Chief of the Pharmaceutical Economy Daily.

　　According to statistics, China’s medical device industry is characterized by a large number of small, fragmented, and low‑end enterprises. Among the 15,000 medical device manufacturers, more than 90% are small and medium-sized firms with annual revenues below RMB 20 million, while only about 300 to 400 companies generate over RMB 100 million in annual sales, indicating a low level of industry concentration. Regional development remains uneven, with the sector concentrated primarily in the Yangtze River Delta—where single-use devices and consumables dominate—the Beijing–Tianjin–Bohai Rim, where digital medical equipment such as DR, MRI, and digital ultrasound is rapidly advancing, and the Pearl River Delta, which excels in comprehensive high‑tech medical devices. Companies invest insufficiently in R&D, exhibit significant disparities in capabilities, and face low domestic market penetration for high‑end equipment.

　　However, in the view of Tao Jianhong, deputy director of the Southern Institute of Pharmaceutical Economics under the CFDA and editor-in-chief of the Pharmaceutical Economic Daily, these objectively existing challenges also represent significant opportunities for the industry. Tao Jianhong points out that, compared with the U.S. market where medical devices and pharmaceuticals account for a 1:1 ratio, China’s market stands at only 1:5, indicating substantial room for growth in the domestic medical device sector. Numerous untapped market segments remain, and the industry’s endogenous growth potential is considerable, with demand poised to be unleashed.

　 　The pace of innovation is accelerating.

　　As evidenced by recent policies—including the 13th Five-Year Plan for the Pharmaceutical Industry, the “Opinions on Reforming the Review and Approval System for Drugs and Medical Devices,” and the “Announcement on Priority Review Procedures for Medical Devices (No. 168 of 2016)” — innovative products with clear clinical advantages have become a key focus of policy support, and innovation has emerged as a buzzword in the medical device sector. On one hand, Chinese medical device companies are increasingly shifting their strategic focus toward R&D, with investment in innovative technology continuously rising; on the other hand, driven by tendering and cost-control measures, the pace of import substitution for high-end medical devices—such as cardiovascular stents and imaging equipment—is accelerating.

　　Tao Jianhong pointed out that, as technological innovation in the high-end medical device sector gains momentum and import substitution becomes increasingly evident, the industry’s rapid growth will be driven primarily by four key factors: an aging population coupled with rising health‑insurance reimbursement levels will sustain market expansion and unleash pent-up demand; domestically produced medical devices are steadily overcoming technical barriers, enabling product upgrades and replacements; tiered diagnosis and treatment policies, along with incentives for private capital to invest in healthcare, are boosting equipment procurement in primary‑care settings and private hospitals, while fiscal support continues to strengthen; and both the share of health spending and the penetration rate of medical devices in China still have considerable room for improvement.

　 　Cultivating Corporate Competitiveness

　　In addition, the “two-invoice system” is gradually being extended to high-value consumables and other medical device sectors, placing higher demands on operating enterprises—such as raising quality standards and establishing traceability systems. Companies that struggle to adapt to this new landscape will face mergers and restructurings, while those with the necessary capabilities can pool their capital to pursue industry‑wide M&A activity.

　　In fact, both manufacturing and distribution companies have long regarded mergers and acquisitions as a key strategy for growth, drawing on the experience of leading European and American medical device firms that expanded from small beginnings. By building an integrated, end-to-end platform encompassing medical devices, pharmaceuticals, healthcare services, and mobile health solutions—through both organic expansion and external acquisitions—companies can enhance their competitive edge.

　　The next decade will be a golden era for China’s medical device industry. How to fully seize the opportunities it presents and proactively pursue sustainable growth is a critical question that every enterprise must address.

　　Parallel Review and Inspection for Class II Medical Device Registration

　　Huang Wei, Researcher at the Certification and Review Center of the Jiangsu Provincial Food and Drug Administration

　　At present, Jiangsu Province ranks among the top nationwide in both the number of medical device manufacturers and the number of registered products. As of the end of 2016, the province was home to 2,187 medical device enterprises, including 1,219 Class II medical device manufacturers, accounting for 55.7% of the provincial total. The province’s total medical device sales amounted to RMB 54 billion, representing approximately 15% of the national total, while the number of registered product varieties reached 12,000, of which 4,000 were Class II devices, or one-third of the total.

　　Huang Wei, a researcher at the Certification and Review Center of the Jiangsu Provincial Food and Drug Administration, stated that Jiangsu’s medical device industry exhibits four key characteristics: first, it comprises a large number of manufacturers, with small and medium-sized enterprises accounting for the majority; only about 100 companies achieve annual sales exceeding RMB 100 million.

　　Second, regional development is uneven, with significant disparities between southern and northern Jiangsu. Suzhou, Wuxi, Changzhou, and Nanjing are home to nearly 1,300 medical device manufacturers, generating total production and sales of close to RMB 40 billion—accounting for more than 70% of the province’s overall output value. Meanwhile, Zhenjiang, Yangzhou, and Taizhou boast over 500 medical device firms, with combined production and sales totaling RMB 9 billion. In contrast, six other cities—including Nantong, Xuzhou, and Lianyungang—have relatively few such enterprises.

　　Third, the province hosts a large number of foreign-invested and joint‑venture enterprises—totaling 100. Globally renowned medical device companies such as Johnson & Johnson, Philips, and Medtronic all operate manufacturing facilities in Jiangsu Province, and most recently, Roche has invested RMB 2.5 billion to establish a production base in Suzhou. Although these foreign‑invested and joint‑venture firms account for only 5% of the province’s total medical device manufacturers, they contribute 45% of the sector’s aggregate production and sales value.

　　Fourth, the concentration of production among enterprises has risen sharply. Governments at all levels attach great importance to the development of pharmaceutical industrial parks and show strong support for the medical device industry. Across the province, there are more than ten parks dedicated to medical devices, with a relatively high degree of enterprise clustering and substantial policy incentives, all of which are conducive to the growth of the medical device sector.

　　Looking at the volume of Class II medical device registration applications accepted in Jiangsu Province, the number has been on an upward trend from 2013 to 2016, with application volumes remaining consistently high. Starting in 2016, a fee was introduced for registration submissions, and this year the number of applications has dropped sharply. This decline can be attributed, on the one hand, to the fact that some companies rushed to file registration applications in 2015 and 2016, and, on the other hand, to the current policy of free medical device testing, which has led to a backlog of products awaiting inspection and excessively long turnaround times, thereby reducing the number of new applications.

　　At present, Jiangsu Province has implemented a combined registration and licensing inspection. For both Class II and Class III medical devices, enterprises within the province may submit applications for both a registration certificate and a manufacturing license simultaneously, with the on-site inspections for registration verification and licensing conducted in a single integrated assessment. Although these two types of inspections have distinct focuses and are governed by different standards, companies need only one on-site visit to obtain both a registration certificate and a manufacturing license, thereby reducing their administrative burden, shortening the time required to secure these approvals, and helping regulatory authorities lower inspection costs.

　 　Two major challenges are hindering the centralized procurement of high-value medical consumables.

　　Liang Hongyun, Section Chief of the Consumables Procurement Division at the Jiangsu Provincial Drug Centralized Procurement Center

　　China’s procurement model for high-value medical consumables has evolved from a past system of decentralized, hospital‑led purchasing to one that now combines provincial and municipal centralized pilot programs with hospital‑level procurement, and further to nationwide unified procurement for key products. Today, the approach is government‑led, with online centralized procurement conducted at the provincial (autonomous region, municipality) level. Under the “Regulations on Centralized Procurement of High‑Value Medical Consumables (Trial),” to date, provinces and municipalities including Anhui, Liaoning, Fujian, Hubei, Jilin, Inner Mongolia, Shandong, Sichuan, Guangxi, Hunan, Henan, Zhejiang, Jiangsu, and Tianjin have all launched such initiatives and issued corresponding work plans for the centralized procurement of high‑value medical consumables.

　　Liang Hongyun, head of the Consumables Procurement Section at the Jiangsu Provincial Centralized Drug Procurement Center, explained that Jiangsu Province has been implementing centralized procurement of medical consumables since 2008—nearly a decade now—but significant challenges persist in practice. On the one hand, even for products with identical names, there is no uniform nomenclature. High-value consumables differ from pharmaceuticals: while drugs are defined by standardized generic names, dosage forms, and specifications—often accompanied by quantifiable criteria—high-value consumables involve a vast array of models and materials. Consequently, there is no standardized naming convention for such items, leading to widespread issues such as different products sharing the same name, the same product being known by multiple names, or different products bearing the same name. At present, no clear national definition of “high-value consumables” exists, and interpretations vary across provinces. Moreover, medical consumables are typically used first and then registered afterward, further complicating efforts to trace product quality, manage hospital billing, and process insurance reimbursements.

　　On the other hand, there is a lack of a unified coding system for procurement and tendering. At present, relevant authorities such as the National Health and Family Planning Commission and industry associations each maintain their own coding systems, with no nationwide standardized system in place. This has resulted in phenomena such as the same product being classified into different groups and significant pricing discrepancies among enterprises for identical product categories.

　　Based on the procurement practices of high-value medical consumables in developed countries and regions, purchasing channels can be broadly categorized into three: direct hospital procurement, national or regional centralized procurement, and third-party commissioned procurement. At the heart of these approaches is the principle of “value for money,” with procurement closely tied to each jurisdiction’s health insurance system. Countries or regions that have implemented universal health insurance tend to favor centralized procurement, and Health Technology Assessment (HTA) plays a significant role in reimbursement decision‑making—lessons that are well worth drawing upon domestically.